Myanmar Industry Overview

Overview

The pharmaceuticals sector is a part of the fast-growing healthcare sector, which incorporates all the drugs, the supplements and injections needed for treatment and health improvement. Many pharmaceuticals and medical equipment in the market are imported from India, China, Bangladesh and Thailand. The rest are from the USA and the Europe. Local pharmaceutical production for western medicine is still in nascent stages and there are only 4 locally owned pharmaceutical production units. According to market research agencies, the total pharmaceutical expenditure in Myanmar has been growing at 11-12% per annum, and has increased from USD 390 million in 2014 to USD 440 million in 2015.
The research figures also point out that total pharmaceutical imports accounted for 85% of the drug market and India takes biggest share with a strong 40-45%. At present, approximately 5000 drug varieties are imported into Myanmar. The market includes generic drugs and all types of prescription drugs including steroids and antibiotics that can be purchased over the counter. According to the World Health Organization, 93% of all medical expenses are borne by patients themselves since government cover and health insurance have yet to be initiated. It is customary for all doctors’ clinics, polyclinics and hospitals to provide medicines, and they have their own sources of procurement from a network of preferred distributors.

Opportunities and Barriers

Opportunities to do joint venture drug manufacturing with the government, drug and medical instrument importation and distributions are very vest for foreign investors. The market is expanding in terms of the quality and range of drugs available, to include supplements and some of the newer, safer drugs. Myanmar people need quality affordable medicine, which those people in rural areas can assess easily. Growth prospects with governmental initiatives are high and the market is expected to touch USD 1.12 billion by 2023. International pharmaceutical companies are coming into Myanmar to exploit a barely tapped market of over 57 million people. If a foreign investor is interested to make an investment in the pharmaceutical sector, it can be done by appointing a business representative, by establishing a branch office, by incorporating a 100% foreign-owned local subsidiary or by forming a joint venture company. Furthermore, manufacturing and marketing of pharmaceuticals are allowed to take place under the Myanmar Foreign Investment Law (‘the MFIL’), with a three-year tax holiday and guarantees against nationalization.

Drugs Importation and Registration

The Ministry of Health sets the drugs importation procedures. Only a Myanmar person or a corporation that is a general registered importer may import registered drugs. In addition to this, the person or the corporation must have a special registration certificate for pharmaceuticals known as a drug importation approval certificate (‘the importation certificate’) and each shipment must also have a separate license, issued by the Ministry of Commerce.All imported drugs have to be registered and authorized by the Food and Drugs Authority that inspects pharmaceutical plants and importers and also tests the quality of drugs. At the moment, there are approximately imported 5000 drug varieties. All imported drugs have to be registered and authorized by the FDA that inspects pharmaceutical plants and importers and also tests the quality of drugs.

The role of traditional medicine

The belief in traditional medicine is strong in Myanmar. This is because those medicines have been followed for generations and continues to be popular, more in remote rural areas where there is no easy access to western (allopathic) medicines. According to statistics provided by the World Health Organization, nearly 75% of Myanmar's population still uses traditional medicines for healing and wellness. Nevertheless, the preference of western medicine over the traditional one is getting higher because traditional ones cannot be used for serious diseases and western medic ions are getting more efficient and more assessable.

Domestic production and the distributor network

The country’s own pharmaceutical industry is grossly underdeveloped with most of the local supplies, accounting for only 20% of the demand, come from the state-owned Myanmar Pharmaceutical Factory that comes under the purview of the Ministry of Industry. The factory has been set up to manufacture tablets, capsules, injections, powders and lotions to initiate the import substitution process. There are over 100 pharmaceutical distributors operating in Myanmar, whose sales force manage to reach even the most remote corners of the country.

Legal & Regulatory Framework

The current law in practicing is still the National Drug Law, which is enacted in 1992. It aims to control and regulate manufacture, import, export, storage, distribution and sale of drugs and protect consumers from counterfeit drugs. There is also “1993 'Narcotic Drugs and Psychotropic Substances Law' and it is being amended. Regarding to Trademark Law, pharmaceuticals may be trademarked in Myanmar. There is no comprehensive trademark statutory scheme in Myanmar. There is no system of registration of trademarks, nor for a statutory title to a trademark. So, the rights of parties setting up rival claims of ownership of a trademark must be determined in accordance with the principles of Common Law. Rights to trademarks in Myanmar are thus dependent on general principles of commercial law.

Drug Manufacturing License

The procedure relating to the application for a drug manufacturer’s license is set by the MOH. To obtain a drug manufacturer’s license, the applicant must apply to the Board through the FDA and the relevant Terms and Conditions. At present, the issuance of all manufacturers’ licenses by the Board has ceased temporarily.

Allowed Types of Investments

Investment businesses permitted with recommendations of Ministry of Industry are production of vaccines and production and distribution of medicine using narcotic drugs and psychotropic substances.
Investment businesses permitted with recommendation of Ministry of Health and Sport are;

1. Private traditional medicine factory and medical clinic
2. Private production and traditional medicine and medicinal items
3. Production of traditional medicine
4. Trading traditional medicinal raw materials
5. Farming and production of traditional medicinal plant
6. Traditional medicine research and laboratory
7. Research operation of vaccine and testing equipment production

Sources

1. European Chamber of Commerce in Myanmar Healthcare Report, November 2016
2. Trade Restrictions Updated, Luther Law Firm Myanmar, January 2016
3. NEW HEALTHCARE RELATED LAWS, VDB Loi Myanmar, 2016
4. Health in Myanmar, 2014